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NCT01700946 · ClinicalTrials.gov registry record · Phase 2
Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT01700946 is a Phase 2 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 80 participants.
The verdict
NCT01700946, a Phase 2 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
The overall objective of this protocol is to improve the cure rate of relapsed precursor B-cell acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma. This phase II trial is studying risk-directed therapy for B-lymphoblastic leukemia or lymphoma in first relapse. Standard risk (SR) and high risk (HR) participants will receive different therapy. Treatment will consist of chemotherapy for SR participants, and chemotherapy followed by hematopoietic stem cell transplant (HSCT) for HR in first relapse. Induction therapy consists of three blocks of chemotherapy. The first block is a novel immunotherapy regimen that includes chemotherapy, rituximab and infusion of haploidentical natural killer (NK) cells. SR participants will continue to receive chemotherapy for a total duration of approximately 2 years. HR participants will be candidates for HSCT and will proceed to transplant once a suitable donor is found and their minimal residual disease (MRD) is negative.
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG dexamethasone
- DRUG clofarabine
- DRUG vincristine sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-04-15 |
| Est. Completion | 2021-07-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01700946
The ClinicalTrials.gov registry entry for NCT01700946 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT01700946 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01700946 about?
NCT01700946 is a clinical study titled "Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma". The overall objective of this protocol is to improve the cure rate of relapsed precursor B-cell acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma. This phase II trial is studying risk-directed therapy for B-lymphoblastic leukemia or lymphoma in first relapse. Standard risk (SR) and high...
What is the current status of trial NCT01700946?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2013-04-15. Estimated completion is 2021-07-24.
What interventions are being tested in trial NCT01700946?
The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), dexamethasone (DRUG), clofarabine (DRUG), vincristine sulfate (DRUG).
Who is sponsoring clinical trial NCT01700946?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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